Differential Contributions of Online Stress and Pain-explicit Mindfulness Treatment Groups to Processes, Patient Experience and Outcomes in Chronic Pain: A Randomized Controlled Trial and Qualitative Analysis
Differential Contributions of Online Stress and Pain-explicit Mindfulness Treatment Groups to Processes, Patient Experience and Outcomes in Chronic Pain: A Randomized Controlled Trial and Qualitative Analysis
Mindfulness is a popular set of knowledge and practical techniques that can help people cope with stress. It includes meditation practices, everyday small practices to break and change usual habits, as well as understanding and developing competencies to be more aware of thoughts, emotions and physical sensations. Mindfulness can help not to excessively react to them, or becoming distressed by these, as well as pain.
In persistent pain (pain that lasts more than three months), mindfulness is thought to improve depression, quality of life, and even how sore people feel.
There are numerous versions of mindfulness and mindfulness-based therapies. One approach, Acceptance and Commitment Therapy (ACT), is based on science (as opposed to religion or common sense). ACT helps people to learn about and apply skills to cope with thoughts, emotions and sensations without getting upset, distracted or impeded by them. It also assists people to develop the ability to set clear goals that matter in their life. ACT evaluates successful outcomes in this areas (called 'processes') and how these link to changes in pain, mood and stress. However, more puritan mindfulness courses tend to only focus on the latter.
Research on mindfulness courses for chronic pain, can show that people improve, but not so well what changes in people's experience and skills, or how such skills are applied. The investigators also know that pain sufferers who attend mindfulness courses for stress, may say it is not so relevant to their pain difficulties.
In this study the investigators want to explore how both mindfulness for stress and mindfulness for pain courses, online, contribute to:
This may help us with better supporting chronic pain sufferers with choices around mindfulness as a standalone or as part of attending intensive pain-coping programmes involving different professions.
Detailed Description
Mindfulness can be defined operationally as Paying attention; on purpose in the present moment and non-judgmentally.
Evidence-based (often referred to as 'secular') mindfulness has seen an exponentially increasing interest in the scientific literature and the estimated number of published scientific journals has recently been reported to have grown from one single journal in 1982, to 667 scientific publications in 2016 and in excess of 30,000 Media Pieces in Newspapers.
However, there are unknowns around the mechanisms (the 'vehicles' of change) by which mindfulness works. These must be better understood in order to avoid continued professional and public misinformation, poor research and ultimately, potential harm to the end user. (Van Dam, van Vugt et al. 2018).
ISSUES WITH AND IMPLICATIONS OF WHAT THE INVESTIGATORS CURRENTLY DEFINE AS MINDFULNESS AND ITS APPLICATION TO CHRONIC PAIN
Within the context of the exponential growth of interest in and research of mindfulness including in the treatment of chronic pain, several factors have contributed to the consideration for the current project:
The integration of mindfulness based interventions in gold-standard multidisciplinary treatments for chronic pain, such as ACT.
Researchers' calls to improve intention to treat, to better understand facets of what is understood to be mindfulness, better targetting of and a more unified approach to mindfulness-change process variables - thus aiming to reduce treatment burden.
There are relevant mindful mechanisms and processes specifically in chronic pain that have made a case from both the ACT and the more purist mindfulness research derived from group based interventions or meditation alone in chronic pain - and that are not currently typically or routinely included in mindfulness groups research for chronic pain.
Methodological issues including
lack of clarity about providers' competencies and requirements in chronic pain,
arbitrary removal of essential components of a given intervention,
often no active or waiting list control condition and
no consideration at all of utilising a theoretically valid and coherent process-measurement frameworks nor consideration for the teachers' competencies requirements when delivering mindfulness courses to chronic pain patients
From reviewing the evidence quoted, the research on mindfulness for chronic pain has exclusively utilised standardised mindfulness groups typically aimed at stress populations, excluded less researched pain explicit (contextually relevant to pain) mindfulness group interventions, ignored theoretically valid mindful-process measurement provided by frameworks such as the ACT framework, or not controlled appropriately for significant confounding factors.
This debate is increasingly important considering that recently published audit data suggests that mindfulness in one format or the other, or as part of ACT-based multidisciplinary treatment is being provided regularly in pain management centres in the UK . This has been leading, possibly prematurely, to discussion about providing training in mindfulness competencies for pain practitioners such as mindfulness enquiry or leading meditations, which may lead, in turn, to implementing professional skills without sound, targeted and theoretically evidenced rationale.
METHODOLOGICAL ISSUES WITH CURRENT MINDFULNESS RESEARCH AND THE IMPROVEMENTS WITH THIS STUDY
The current research will therefore aim to address and control, some of the currently reported methodological issues in research on group mindfulness based interventions (MBIs), including:
Identified Risks Likelihood Potential Impact/Outcome Risk Management/Mitigating Factors:
Practicing mindfulness meditation has been known to trigger distressing memories in patients with existing Trauma/PTSD
Low
Participant:
• Psychological Stress
Researcher
Discussion of sensitive topics in interview has potential to cause distress to participant
Low Participant:
• Psychological Stress
Researcher
Conflict between participants in group setting
Low Participant:
• Psychological Stress
Researcher
Data collection & interviews may possibly take place in an unfamiliar location with people not already known to the researcher
High
Researcher
Disclosure of information about poor practice
Low Immediate, urgent or prompt response may be required from service providers • Ensure all verbal and written information about research indicates possible researcher response to disclosure
• The researcher will be able to signpost participant to the relevant support services
Disclosure of unmet health or social care needs
Medium Immediate, urgent or prompt response may be required from service providers • Ensure all verbal and written information about research indicates possible researcher response to disclosure
• The researcher will be able to signpost participant to the relevant support services
Research participant in danger of harm to self or others
Low Immediate, urgent or prompt response may be required from service providers • Ensure all verbal and written information about research indicates possible researcher response to disclosure
• The researcher will be able to signpost participant to the relevant support services
STATISTICAL POWER This study will be a modification of a previous pilot test trial of a brief, widely inclusive UK primary care setting (McCracken, Sato and Taylor, 2013), to include the whole sample of participants acting as a waiting list control, randomly allocated to two active treatment conditions. In line with this study which was delivered in a population area of 119,000 people, power calculations were not completed, nor were formal predictions of significant treatment effects. This was on the basis that the same treatment format and in a community based sample had not been tried before and demonstrated of successful recruitment of > 60 participants within a two-month period and reporting moderate effect sizes for the active condition. Given the whole island population of Jersey (N.B. this is United Kingdom Jersey - not US) is estimated currently at 106,000, power calculations will not be provided in this study as the sample size was deemed appropriate in the previous that also cited a number of studies with similar sample sizes and obtained from populations greater than Jersey.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results: The investigators will utilise mean substitution for missing items or alternative substitution technique.
The quantitative analysis will be also bolstered by a qualitative study:
DESIGN AND SETTING A qualitative study involving semi-structured interviews will be held, with a topic guide informed by the ACT psychological flexibility model and Day's framework for mindfulness-relevant processes in chronic pain, and based on mindfulness research improvement based on adaptations of Mindfulness Based Cognitive Therapy (MBCT) for chronic pain
Exclusion criteria (in addition to quantitative study criteria):
Non-completers (participants who completed less than 6/8 course sessions) Declined to take part in interviews
SAMPLING An opportunity sample from all patients invited to take part to the quantitative research aspect, invited as part of the initial quantitative study informed consent process.
We will invite all participants from the sample, aiming from 10-15 participants from each the stress and pain version of the courses, hence a total sample of 30 participants maximum and a target of 10 completed interviews for each intervention.
N.B. This study's initial Ethics Submission was for a face to face project in February 2019. However, due to Covid-19 and lack of funding, the investigators requested and agreed Ethics amendments to go online. These amendments were approved by the Jersey Healthcare Ethics Committee after submission on 24/05/2022, their meeting on 26/05/2022 and formal email of approval on 30/05/2022.
Once potential participants have consented, searches will be run on GP electronic health records to identify suitability. Demographic data including gender, age, ethnicity and employment status, pain diagnoses, current medication and dosage, co-morbidities and mental health diagnoses will be extracted via GP referral to the study, including that the patients meet inclusion criteria and do not meet any of the exclusions.
INCLUSION CRITERIA
EXCLUSION CRITERIA